Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars

Reversible Pulpitis Clinical Trial

Official title:

Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433297
• Other study ID #: Soma Chanakya
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: December 23, 2025

Study information

• Verified date: May 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Dr. Vinay Kumar, MDS
• Phone: 8901149107
• Email: 29vinaykr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Objectives:

1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Description:

Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristics, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which corresponds to irreversible pulpitis. Vital pulp therapy is suggested to be the choice of treatment for such cases. It has been suggested that infection is often a cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Partial caries removal, which involves complete removal of carious dentine from the surrounding cavity walls, followed by the partial removal of infected dentin at the pulpal wall which reduce chances of pulp exposure followed by placement of medicament for Indirect pulp capping. Whereas during Complete caries removal, caries is completely removed from surrounding walls as well as on pulpal wall which increase the chances of pulp exposure followed by placement of medicament for Direct pulp capping procedure. Based on this premise, IPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of direct pulp capping, partial pulpotomy or full pulpotomy in adults.

Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis? P (Population) - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I (Intervention) - Partial caries removal followed by Indirect pulp capping C (Comparison) - Complete caries removal followed by Direct pulp capping O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.

• To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 23, 2025
• Est. primary completion date: December 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient should be =18 years of age.

2. Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine)

3. Tooth should give positive response to pulp sensibility testing.

4. Clinical diagnosis of moderate pulpitis.

5. Radiographic finding of periapical index (PAI) score =2.

6. Healthy periodontium (probing pocket depth =3 mm and mobility within normal limit).

7. Pulp exposure after complete caries excavation.

8. No pulp exposure after incomplete caries excavation

Exclusion Criteria:

1. Teeth with immature roots.

2. Pulp exposure after incomplete caries excavation.

3. No pulp exposure after complete caries excavation.

4. Bleeding could not be controlled in 5 minutes.

5. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.

6. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.

7. Internal/external resorption.

8. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

Related Conditions & MeSH terms

• Indirect Pulp Capping
• Pulpitis
• Reversible Pulpitis

Intervention

Procedure:
• INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS
After partial caries removal the cavity is disinfected, dried, and capped with a 2-3mm layer of MTA followed by a light-cured resin layer. The tooth is then definitively restored with composite. Following complete caries removal, any bleeding pulp will be controlled with sodium hypochlorite for up to 5 minutes. Exposed pulp will then be directly capped with a 2-3mm layer of MTA, followed by a light-cured resin layer and definitive composite restoration using an etch-and-rinse technique.

Locations

Country	Name	City	State
India	PGIDS, Rohtak	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success Rate	No history of spontaneous pain or discomfort except for the initial days after treatment.; No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.	Base line to 12 months
Primary	Radiographic success	No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al.	Base line to 12 months
Secondary	Pain incidence and reduction	Post operative pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to100 millimeter line.	Baseline to seven days